Method for filling and sealing plastic ampoules

ABSTRACT

An ampoule for a hypodermic jet injector. The end of the ampoule, through which medicament passes, is constructed of a resilient material. Cross-cuts are scribed in the resilient end so that a plunger driving a plug into the opposite end of the ampoule forces medicament through the cross-cut end by bursting it along lines coincident with the cuts. Alternate end cuts, a storage case, and methods for filling the ampoules are also disclosed.

United States Patent M r land 1 51 Mar. 21, 1972 [54] METHOD FOR FILLINGAND SEALING References Cited PLASTIC AMPOULES UNITED STATES PATENTS [721Mm'andv Gmsse Pime 107,582 9/1870 Wolfe et a1. ..53/32o 2,501,652 3/1950Barrickman ..53/37 [73] Assignee: R. P. Scherer Corporation 2,645,338-7/1953 Scherer 128/173 H UX I 3,267,636 8/1966 Stemberg ..53/353,552,095 1/1971 Inman ..141/247 x 211 Appl. No; 4,884

Primary Examiner-Edward .l. Earls Related Application DataAttorney-Molinare, Allegretti, Newitt & Witcoff [62] Division of Ser.No. 697,891, Jan. 15, 1968, Pat. No.

3 540 444 [57] ABSTRACT An ampoule for a hypodermic jet injector. Theend of the am- [52] U.S. Cl ..53/37,li3l/23,15:fifi8i poule throughwhich medicament passes, is constructed of a 51 I t 1565b 7/28 resilientmaterial. Cross-cuts are scribed in the resilient end so E g 267 268that a plunger driving a plug into the opposite end of the ampouleforces medicament through the cross-cut end by bursting it along linescoincident with the cuts. Alternate end cuts, a storage case, andmethods for f lling the ampoules are also disclosed.

1 Claims, 16 Drawing Figures EATENTED MAR 21 I972 SHEET 1 BF 3 Sig 06272I'M/oreland PATENTEDMARZI I972 9, 650,084

sum 2 UF 3 II'I'IJIIIIIIIIIIII I l 22 H i I 2/6 72507: 525 070427; 77.Morelana? METHOD FOR FILLING AND SEALING PLASTIC AMPOULES CROSSREFERENCE TO A RELATED APPLICATION This is a division of applicationSer. No. 697,891, filed Jan. 15, 1968, now U.S. Pat. No. 3,540,444.

BACKGROUND OF THE INVENTION This invention relates to an improved ampulfor use with a hypodermic jet injector and a method of filling theampul.

There are presently available various types of hypodermic jet injectordevices. Typical of those available is the one shown in U.S. Pat. No.2,754,818 granted to Scherer on July 17 1956. In a jet injector of thetype disclosed by Scherer, an ampul filled with medicament is positionedin the discharge end of the injector. The ampul includes a main bodysection, which is usually formed from a stainless steel material, and aplug which fits in an open end of the ampul.

The plug is driven by a plunger of the jet injector into the body of theampul forcing medicament out through an opening in the opposite end ofthe ampul and through the nozzle orifice of the jet injector. Medicamentwhich passes through the nozzle orifice then pierces the skin of thepatient and enters the patient. Such a device has been quite favorablyreceived and is especially useful for mass innoculation programs.

A type of ampul heretofore utilized with a hypodermic jet injector isdisclosed in U.S. Pat. No. 2,688,968 granted to Scherer, on Sept. 14,1954. Such an ampul includes an opening in one end of the capsule forthe passage of medicament and a displaceable driving plug at theopposite end of the ampul. While these ampuls are very satisfactory,they are not transparent which is a desirable characteristic for ampuls.Moreover ampuls of this construction make direct contact with thepatients skin, the medicament being discharged through the orifice inthe ampul. Thus, protection against slippage of the ampul by a dischargenozzle attached to the jet injector and especially constructed toprevent slippage is not possible.

SUMMARY OF THE INVENTION In a principal aspect the present inventioncomprises an improved ampul for use with a hypodermic jet injector, theampul being comprised of a cylindrically shaped capsule with one openend and a plug which fits into the open end. The opposite end of thecapsule is rounded and is made from a flexible material. The rounded endhas a pattern of cuts. Thus the pressure created inside the ampul byforcing a plunger against the plug causes the closed end to burst alongseams coincident with the cuts in the closed end. There is alsodisclosed a method of filling the ampuls with medicament in addition tovarious embodiments of the invention and packaging means for theimproved ampul.

It is thus an object of the present invention to provide an improvedampul for use with a hypodermic jet injector unit.

It is a further object of the present invention to provide a rugged yeteconomical ampul for use with a hypodermic jet injector unit.

Still another object of the present invention is to provide a method forfilling the improved ampul with medicament.

One further object of the present invention is to provide an improvedampul with a corresponding improved nozzle construction.

These and other objects, advantages and features of the presentinvention will be more fully understood by reference to the detaileddescription which follows.

BRIEF DESCRIPTION OF THE DRAWINGS In the detailed description whichfollows, reference will be made to the drawings which include thefollowing figures:

FIG. 1 is a side cross-sectional view of a first embodiment of theimproved ampul in a container case;

FIG. 2 is a left-hand end view of the embodiment shown' in FIG. 1;

FIG. 3 is a cross-sectional view of the embodiment shown in FIG. 1 takensubstantially along the line 3-3 in FIG. 1;

FIG. 4 is a cross-sectional view of the ampul of FIG. 1 as positioned ina hypodermic jet injector before medicament has been forced therefrom;

FIG. 5 is a cross-sectional view of the ampul and jet injectorillustrated in FIG. 4 positioned in contact with the skin of a patient;

FIG. 6 is a cross-sectional view of the improved ampul of FIG. 1following depression of the plunger and plug to force medicament fromthe ampul through the jet injector nozzle;

1 FIG. 7 is an end view of the first embodiment of the ampul; I

ampulj FIG. 8 is a cross-sectional view of a second preferred embodimentof the ampul;

FIG. 9 is an end view of the embodiment shown in FIG. 8;

FIG. 10 is a cross-sectional view of the embodiment shown DESCRIPTION OFTHE PREFERRED EMBODIMENTS FIGS. 1 through 7 illustrate a first preferredembodiment of the present invention, FIGS. 8 through 11 illustrate asecond preferred embodiment, FIGS. 12 through 14 illustrate a method forfilling the embodiment illustrated in FIGS. 1 through 7 with medicament,and FIGS. 15 and 16 illustrate a method for filling the embodimentillustrated in FIGS. 8 through 11 with medicament.

Referring now to FIGS. 1 through 7, those of the first preferredembodiment, there is shown in FIG. 4 the front end portion of a typicalhypodermic jet injector unit, for example, of the type shown by Schererin U.S. Pat. No. 2,754,818. The ampul of the invention, generally shownat 12, is positioned in chamber 14 defined in nozzle 16. The nozzle 16is threadably attached to body 18 of the hypodermic jet injector unit.Within the body 18 is a plunger 20 which is driven by driving means (notshown). The plunger 20 can thus be moved to the left of its positionillustrated in FIG. 4 to cause medicament to be discharged from theampul 12 through the end of the nozzle 16. A bumper 22 is provided toengage the plunger 20 at the end of the driving stroke.

The nozzle 16 includes a central orifice 24 leading from the chamber 14through a flared section 26. The flared section 26 is normally notoccupied by medicament or the ampul 12 but is necessary for properdischarge of the medicament from the ampul 12 as will be describedbelow.

The ampul 12 includes a cylindrically shaped body or capsule 28 havingan open end to receive a plug or stopper 29. A circumferential flange 30surrounds the open end of the cap sule 28. When the ampul 12 is insertedinto the chamber 14, the flange 30 coacts with the nozzle 16 toprecisely position the ampul 12 at a fixed depth within the chamber 14,to provide a seal between the nozzle 16 and the body 18, and to securethe ampul 12 in a precise position in relation to the nozzle 16 and thebody 18. The capsule 28 includes a circumferential ridge 32 around theinside of the end opposite the flange 30.

The ampul 12 also includes a closed end section 34 which is preferablyrounded and adapted to fit into the end of the capsule 28 opposite plug29. The closed or rounded end section 34 includes a circumferentialgroove 36 adapted to mate with the ridge 32 and hold the rounded endsection 34 in a snug intimate relation with the capsule 28. The roundedend section 34 is preferably fabricated from a soft, resilient materialsuch as rubber or the like. 1

As more fully illustrated in FIG. 7 the rounded end portion includes aplurality of cuts 38, 39, 40 and 41 which meet at a common point at thecenter of the rounded end 34. The cuts pass completely through therounded end section 34. Thus, when pressure is exerted on a volume ofmedicament 47 within the ampul 12, the sections of the rounded end 34,between adjacent cuts, 38 and 39, 39 and 40, 40 and 41, 41 and 38 areforced apart to allow medicament 47 to pass out the rounded end 34.

The stopper or plug 29, as shown in FIG. 4, inserted in the open end ofthe capsule 28 assures that medicament 47 is maintained within the ampul12. During operation of the hypodermic jet injector, the plunger 20 fitsagainst stopper 29 and pushes the stopper 29 into the capsule 28 todrive medicament 47 from the ampul 12.

Referring now to FIGS. and 6, there is illustrated the sequence ofoperations during discharge of medicament 47 from the jet injector. InFIG. 5 the nozzle 16 has been positioned against the skin 52 of apatient. Slight pressure is maintained on the nozzle 16 so that part ofthe nozzle 16 in the region of the orifice 24 causes a slight depressionin the layers of skin 52 and 53 and flesh 49.

FIG. 6 illustrates the next step in the sequence of operations. In FIG.6 the plunger 20 has been depressed to drive the stopper 29 into thecapsule 28 thereby causing medicament 47 to be forced through therounded end section 34 of the ampul 12 into the flared section 26 of thechamber 14. Medicament then passes out through the orifice 24 of thenozzle 16. A stream of medicament 47 passing through the orifice 24pierces the layers of skin 52 and 53 and passes into the flesh 49 of thepatient.

The rounded end section 34 of the ampul 12 splits along lines 38 through41 as set forth above to define four flaps, for example, flap 55 in FIG.6 between cuts 38 and 41. The flaps, as at 55, fit into the flaredsection 26 of the chamber 14 without inhibiting the movement ofmedicament 47 through the orifice 24.

FIGS. 1, 2 and 3 show the ampul of the invention enclosed in a storagecase. The case includes a cylindrically shaped cartridge 57 fabricatedfrom a plastic material and adapted to receive the ampul through an openend. A triangular-shaped rubber liner or spacer 59 is positioned on thebottom of the cartridge 57. The medicament filled ampul 12 is insertedinto the cylindrical cartridge 57 to rest on the spacer 59. A secondrubber liner or spacer 60 fits over the rounded end 34 of the ampul l2.Liner 60 provides a seal around the open top end of the cartridge 57.

A cap or closure 62 holds the liner 60 in position within the cartridge57 and provides an airtight seal within the cartridge 57. Thus ampul 12is held in a substantially immovable position and is protected againstbumping and possible rupture or contamination. The spaces between theampul 12 and the interior walls of the cartridge have preferably beenpurged of air and filled with an inert gas to prevent aging anddeterioration of the medicament.

FIGS. 8 through 11 show a second preferred embodiment of the invention.As illustrated in FIG. the second embodiment of an ampul 64 is adaptedto fit into the hypodermic jet injector having the same components aspreviously described for the first preferred embodiment of an ampul 12.

FIG. 8 illustrates the second embodiment of the ampul 64 in a packagedform. The ampul 64 includes a capsule 66 with a plug or stopper 68inserted in an open end of capsule 66. The plug 68 is preferablyfabricated from a self-healing rubber. The capsule 66 is preferablyfabricated from a polycarbonatetype, clear, transparent plasticmaterial, compatible with injectable medicaments. The lower or roundedend portion of the capsule 66 has thinner walls than the main sidecylindrical walls of the capsule 66; however, the capsule is a singleintegral molded piece in contrast to ampul 12 which includes a separablerounded end 34 and a capsule 28. The thin walls of the rounded end ofcapsule 66 assure that the rounded end portion of the capsule 66 will bemore flexible than the main side walls of capsule 66.

The capsule 66 also includes a circumferential flange 70 around itsmolded open end which is utilized in the same manner previouslydescribed for the ampul l2; namely, as a holding and sealing meansbetween the nozzle 12 and the body 18 of the jet injector. The flange 70for the ampul 64 also cooperates with a tear-off aluminum closure seal72 utilized in packaging the ampul 64 to hold the seal 72 on the capsule66. A gasket 74 is positioned between the seal 72 and the flange 70 toinsure a complete, airtight seal of the packaged ampul 64.

Referring now to FIGS. 9 and 11 there is shown the end construction ofthe ampul 64. Whereas in the first embodiment ampul 12 cuts were madeentirely through the rounded end 34 of the ampul 12, now diagonalreductions 76 and 77 in the thickness of the wall are formed in theouter surface of the nose of the capsule 66. The diagonal reduction 76and 77 in the thickness of the capsule wall intersect at substantiallyright angles. FIG. 8 illustrates a cross-sectional view of theconfiguration of the reductions 76 and 77 in the thickness of the wallin the nose of the capsule 66.

When the plunger 20 is depressed forcing the stopper 68 to drivemedicament 47 from the ampul 64, the rounded end of the capsule 66ruptures along the lines defined by the reductions 76 and 77 inthickness of the nose of the capsule 66. This is illustrated in FIG. 11.Medicament 47 thus may pass through the ruptured opening and through theorifice 24 into a patient in the same manner as previously described forthe ampul 12.

As has been illustrated in the first preferred embodiment of the ampul12 and the second preferred embodiment of the ampul 64 there may be adetachable rounded end section or an integral rounded end section, andthere may be cuts passing completely through the rounded end section orcuts passing partially through the rounded end section. There has beenillustrated only two combinations of these features; namely, an integralrounded end with cuts partially therethrough (ampul 64) and a detachablerounded end with cuts entirely therethrough (ampul 12). Othercombinations are quite possible and the invention is not limited tothose preferred embodiments disclosed herein.

Referring now to FIGS. 12 through 14, there is shown a method forfilling an ampul of the type having cuts entirely through the roundedend section. FIG. 12 shows schematically the first step in theoperation. A stopper or plug 76 is positioned on top of a rod 78 beneaththe chamber 80 in chamber assembly 82. The chamber assembly 82 is freelyslidable on the rod 78 and may slide to engage any of a number ofstepwise stops on a rotatable tube 83 to thereby position the chamberassembly 82 in relation to the rod 78. As illustrated in FIG. 12 stop 84has engaged the chamber assembly 82 so that the stopper 76 may bepositioned within the slot at the side of the chamber assembly 82 and ontop of the rod 78.

The next step is illustrated in FIG. 13. The chamber assembly 82 isengaged by the stop 86. The chamber assembly 82 thus drops down over therod 78 and stopper 76 to close the chamber 80 at the bottom end.Medicament 88 is then poured into the chamber 80 of the chamber assembly82.

In the next step illustrated in FIG. 14 an ampul body carrier 90 with anampul capsule 91 situated on the interior thereof, is fixedly positionedover the end of the chamber assembly 82. The body carrier 90 is held inposition by the locking cylinder 92 which threadably engages the chamberassembly 82.

The chamber assembly 82 finally engages the bottom stop 94. This causesthe rod 78 to force the plug up into the ampul capsule 91.Simultaneously any extra medicament 88 is forced through a passage 96defined in the top of the body carrier 90. The locking assembly 92 isthen removed to permit the removal of the body carrier 90 and the filledampul. As can be appreciated by examination of FIG. 14, this method offilling an ampul will work only for an ampul of the type having cutscompletely through the rounded end of the ampul.

The apparatus disclosed for carrying out the method of filling ampuls isfor laboratory use. In a mechanized filling apparatus for productionline use, there would probably be a multiplicity of rods, such as 78,mounted on a rotary indexing table, the chamber would then be driven tosuccessive filling stations by a cam mechanism.

FIGS. and 16 illustrate a method of filling an ampul of the type havingreductions molded partially through the rounded end such as ampul 64previously described. Referring first to H6. 15, the ampul capsule 97 isinserted into a chamber 98 in the block 100 with the rounded end downand the open end up. The ampul capsule 97 is then filled with medicament101.

F l0. 16 illustrates the following steps. A stopper 103 is fixed to aplunger 104 having a hollow needle 105 passing therethrough. The plungeris then lowered to direct the stopper 103 into the open end of thecapsule 97. Excess medicament 101 passes through the hollow needle 105.The plunger 104 is then lifted simultaneously withdrawing the hollowneedle 105 from the stopper 103. The stopper 103, which is fabricatedfrom a self-sealing rubber, then seals the medicament within the capsule97. The filled ampul may then be removed from the block 100.

While there has been disclosed preferred embodiments of the ampul of thepresent invention and methods for filling these embodiments withmedicament, it is to be understood that all those embodiments obvious topersons skilled in the art and all those embodiments which areequivalent to the presently claimed subject matter are to be includedwithin the scope of the appended claims.

I claim:

1. A method for loading medicament into an ampul of the type for usewith a hypodermic jet injector unit, wherein said ampul comprises acylindrically shaped capsule having one open end, one closed end, aninside and an outside, said closed end formed from a flexible,rupturable material and having defined therein a plurality of cuts suchthat a pressure differential between the inside and outside of saidampul causes medicament to pass in the direction of decreasing pressurethrough an opening in said closed end defined by rupture of said closedend along said cuts; and a plug fitted into said open end of said ampulto thereby define an enclosed chamber within said ampul for holdingmedicament, said plug being slidable along the inside of said ampul tocause pressure differential between the inside and outside of saidampul, said method comprising the steps of:

positioning said plug on top of a vertical loading rod,

forcing said plug into a cylindrical chamber,

filling said chamber with medicament,

attaching said capsule to the top of said chamber with said open enddown, and

forcing said plug and medicament from said chamber and up into saidcapsule.

1. A method for loading medicament into an ampul of the type for usewith a hypodermic jet injector unit, wherein said ampul comprises acylindrically shaped capsule having one open end, one closed end, aninside and an outside, said closed end formed from a flexible,rupturable material and having defined therein a plurality of cuts suchthat a pressure differential between the inside and outside of saidampul causes medicament to pass in the direction of decreasing pressurethrough an opening in said closed end defined by rupture of said closedend along said cuts; and a plug fitted into said open end of said ampulto thereby define an enclosed chamber within said ampul for holdingmedicament, said plug being slidable along the inside of said ampul tocause pressure differential between the inside and outside of saidampul, said method comprising the steps of: positioning said plug on topof a vertical loading rod, forcing said plug into a cylindrical chamber,filling said chamber with medicament, attaching said capsule to the topof said chamber with said open end down, and forcing said plug andMedicament from said chamber and up into said capsule.